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FDA s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers By Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc. In January 2021, as one of his last official acts as the Commissioner of the FDA, Stephen Hahn, M.D., published the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report. 1 The PREPP report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response spanning FDA policies, processes, operations, communications, and intra-agency coordination to the global COVID-19 pandemic. 2 The FDA asked an independent non-government organization to conduct an objective review of its ongoing COVID-19 response and to summarize findings in the PREPP report. To that end, the third-party organization solicited insights from key FDA staff and external stakeholders, collated lessons learned, and suggested 12 p

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